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Chembio Diagnostics Q3 Revenues Rise 6 Percent, Submits New EUA for SARS-CoV-2 Serology Test

NEW YORK – Chembio Diagnostics reported after the close of the market on Thursday that its third quarter revenues grew 6 percent year over year. 

For the three months ended Sept. 30, Chembio reported revenues of $10.3 million compared to $9.7 million in the prior-year quarter, and beating analysts' average estimate of $3.9 million.

The company's Q3 net product sales fell 1 percent to $8.4 million from $8.5 million. R&D and grant revenues grew 75 percent year over year to $1.7 million from $971,980 million, and license and royalty revenues fell 11 percent year over year to $211,521 from $238,330.

The Hauppauge, New York-based company said Thursday that it has submitted new EUA applications to the US Food and Drug Administration for its DPP SARS-CoV-2 IgM/IgG test system and DPP SARS-CoV-2 Antigen test system, which was funded with the support of the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA).

The firm further noted that it recently received FDA premarket approval for its DPP HIV-Syphilis System.

"The potential launch of antigen and antibody test systems that leverage the DPP platform will provide much needed and expanded access to decentralized COVID-19 testing amid the resurgence of cases across the US," Richard Eberly, Chembio’s president and CEO, said in a statement. "Running both types of tests on the same micro reader analyzer will enable clinicians to address the needs of a broader patient population throughout all phases of the pandemic."

Eberly added that its third quarter revenues included sales of its DPP COVID-19 IgM/IgG systems shipped outside the US in the second quarter. In the quarter, Chembio "made significant progress on product development and regulatory fronts," he added on a call to discuss the company's financial results.

The firm had set goals of submitting applications to the US Food and Drug Administration for Emergency Use Authorization of new antibody- and antigen-based tests for COVID-19 by the end of the third and fourth quarters, respectively. "We accomplished the milestones ahead of schedule with submissions in early September and early October, respectively," Eberly said.

He added that the firm is seeking a CLIA waiver, as part of its EUA submission, for its antigen test, which would enable its use in a "greater variety of less complex settings."

He also commented on FDA's revocation of an EUA the agency had granted for Chembio's DPP COVID-19 IgM/IgG test in April because of concerns about its sensitivity and specificity.

"In June, two months following the EUA, the FDA implemented a new methodology to evaluate antibody tests and the results of that change triggered the revocation of the EUA for our antibody test," Eberly said.

According to FDA documents, it revoked the EUA after the National Cancer Institute performed a validation of the test.

For the third quarter, the firm's net loss widened to $5.5 million, or $.28 per share, from a loss of $3.8 million, or $.22 per share, in the prior-year quarter, and missed analysts' average estimate for a loss of $.26 per share.

Chembio's Q3 R&D spending rose 9 percent to $2.4 million from $2.2 million a year earlier while SG&A expenses increased 18 percent year over year to $5.3 million from $4.5 million. 

At the end of September, Chembio had $28.7 million in cash and cash equivalents.

Chembio shares were up more than 4 percent to $4.62 in Friday morning trading on the Nasdaq.